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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00778609




Registration number
NCT00778609
Ethics application status
Date submitted
22/10/2008
Date registered
23/10/2008
Date last updated
14/01/2016

Titles & IDs
Public title
Effect of a New Oral Contraceptive Pill on Hormone Related Symptoms Such as Pelvic Pain and Headache
Scientific title
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Microgynon on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment
Secondary ID [1] 0 0
310787
Secondary ID [2] 0 0
91550
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Contraceptive 0 0
Headache 0 0
Pelvic Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - EV/DNG (Qlaira, BAY86-5027)
Treatment: Drugs - Encapsulated Microgynon + Placebo

Experimental: Arm 1 -

Active Comparator: Arm 2 -


Treatment: Drugs: EV/DNG (Qlaira, BAY86-5027)
Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one capsule SH T00658ID for 28 days per cycle for 6 treatment cycles no pill-free interval

Treatment: Drugs: Encapsulated Microgynon + Placebo
Day 1 to 21; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Day 22 to 28 placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare SH T00658ID (Qlaira) to Microgynon with regard to changes in frequency and intensity of the hormone withdrawal associated symptoms headache and pelvic pain on cycle days 22-28 combined into a single endpoint
Timepoint [1] 0 0
Baseline to cycle 6
Secondary outcome [1] 0 0
Rescue medication consumption
Timepoint [1] 0 0
Baseline to cycle 6
Secondary outcome [2] 0 0
Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting) during cycle days 22 to 28
Timepoint [2] 0 0
Baseline to cycle 6
Secondary outcome [3] 0 0
Prevalence of individual hormone-related symptoms during cycle days 1 to 21
Timepoint [3] 0 0
Baseline to cycle 6
Secondary outcome [4] 0 0
Prevalence of individual hormone-related symptoms during hormone-free interval, i.e. cycle days 27+28 for EV/DNG capsules and cycle days 22 to 28 for the comparator
Timepoint [4] 0 0
Baseline, cycle 3 and cycle 6
Secondary outcome [5] 0 0
Change in the average of the 3 highest VAS values of the hormone withdrawal associated symptoms pelvic pain or headache during cycle days 22 to 28 from baseline to cycle 3
Timepoint [5] 0 0
Baseline to cycle 3
Secondary outcome [6] 0 0
Bleeding pattern and cycle control
Timepoint [6] 0 0
Throughout
Secondary outcome [7] 0 0
QoL Questionnaires: Psychological General Well-Being Index (PGWBI), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Clinical Global Index (CGI)
Timepoint [7] 0 0
Baseline, cycle 2 and cycle 5
Secondary outcome [8] 0 0
AEs and SAEs. Concomitant medication. Vital signs (heart rate and blood pressure). Body weight
Timepoint [8] 0 0
Throughout
Secondary outcome [9] 0 0
General physical and gynecological examination
Timepoint [9] 0 0
Screening and Final Visit

Eligibility
Key inclusion criteria
- Age between 18 and 50 years (inclusive) at visit 1, for smokers up to 35 years
(inclusive)

- Otherwise healthy female subjects requesting contraception and currently using a
levonorgestrel, gestodene or desogestrel containing oral contraceptive in a 21-day
regimen and suffering from at least moderate pelvic pain, headache or both defined by
an average value of >/= 35 mm for the 3 highest values on a visual analogue scale
during cycle days 22-28.

- Normal or clinically insignificant cervical smear not requiring further follow up (or
a normal result obtained within the last 6 months before screening)

- Able to tolerate ibuprofen and willing to use only ibuprofen supplied for the study.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women with any contraindication for oral contraceptive use

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
449
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Ashfield
Recruitment hospital [2] 0 0
- Blacktown
Recruitment hospital [3] 0 0
- Caringbah
Recruitment hospital [4] 0 0
- Sydney
Recruitment hospital [5] 0 0
- Fortitude Valley
Recruitment hospital [6] 0 0
- Kipparing
Recruitment hospital [7] 0 0
- Adelaide
Recruitment hospital [8] 0 0
- Norwood
Recruitment hospital [9] 0 0
- Clayton
Recruitment hospital [10] 0 0
- Nedlands
Recruitment hospital [11] 0 0
- Subiaco
Recruitment postcode(s) [1] 0 0
2031 - Ashfield
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2229 - Caringbah
Recruitment postcode(s) [4] 0 0
2031 - Sydney
Recruitment postcode(s) [5] 0 0
4006 - Fortitude Valley
Recruitment postcode(s) [6] 0 0
4021 - Kipparing
Recruitment postcode(s) [7] 0 0
5005 - Adelaide
Recruitment postcode(s) [8] 0 0
5065 - Norwood
Recruitment postcode(s) [9] 0 0
3163 - Clayton
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment postcode(s) [11] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Helsinki
Country [2] 0 0
Finland
State/province [2] 0 0
Kuopio
Country [3] 0 0
France
State/province [3] 0 0
Brignoles
Country [4] 0 0
France
State/province [4] 0 0
Maison Lafitte
Country [5] 0 0
France
State/province [5] 0 0
Nancy
Country [6] 0 0
France
State/province [6] 0 0
Nantes
Country [7] 0 0
France
State/province [7] 0 0
Olivet
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
France
State/province [9] 0 0
Saint Germain En Laye
Country [10] 0 0
France
State/province [10] 0 0
Seclin
Country [11] 0 0
France
State/province [11] 0 0
Tarare
Country [12] 0 0
France
State/province [12] 0 0
Toulouse
Country [13] 0 0
Germany
State/province [13] 0 0
Baden-Württemberg
Country [14] 0 0
Germany
State/province [14] 0 0
Hessen
Country [15] 0 0
Germany
State/province [15] 0 0
Niedersachsen
Country [16] 0 0
Germany
State/province [16] 0 0
Nordrhein-Westfalen
Country [17] 0 0
Germany
State/province [17] 0 0
Sachsen-Anhalt
Country [18] 0 0
Germany
State/province [18] 0 0
Sachsen
Country [19] 0 0
Germany
State/province [19] 0 0
Schleswig-Holstein
Country [20] 0 0
Germany
State/province [20] 0 0
Hamburg
Country [21] 0 0
Mexico
State/province [21] 0 0
México
Country [22] 0 0
Mexico
State/province [22] 0 0
Sonora
Country [23] 0 0
Mexico
State/province [23] 0 0
Mexico, D.F.
Country [24] 0 0
Mexico
State/province [24] 0 0
México, D.F.
Country [25] 0 0
Spain
State/province [25] 0 0
Alicante
Country [26] 0 0
Spain
State/province [26] 0 0
Asturias
Country [27] 0 0
Spain
State/province [27] 0 0
Catalunya
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Switzerland
State/province [30] 0 0
Basel-Stadt
Country [31] 0 0
Switzerland
State/province [31] 0 0
Bern
Country [32] 0 0
Switzerland
State/province [32] 0 0
Zürich
Country [33] 0 0
Thailand
State/province [33] 0 0
Bangkok
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Cheshire
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Middlesex
Country [36] 0 0
United Kingdom
State/province [36] 0 0
North Somerset
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Nottinghamshire
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Stratchclyde
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of the present study is to investigate whether women taking a new combined oral
contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone
withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle
compared to a commonly used contraceptive pill (Microgynon).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00778609
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00778609